MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y399H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 device not returned.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please explain why the patient was hospitalized and provide details about the hospitalization.Please provide the patient's demographic information including age, weight, bmi at the time of index procedure.Date of index surgical procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? what instruments were used to grasp the needle? where was the needle grasped during use? does the needle piece remain retained in the patient's tissue? if the piece(s) were retained, where are they located/in what structure? if retained, were there any patient consequences? if retained, are there plans for removal of any remaining fragments? please describe any medical/surgical intervention required for this suture event including dates and results.Other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? will product be returned? if so, please provide the return date and tracking information.
Event or Problem Description
It was reported that a patient underwent an open myomectomy on an unknown date and suture was used on the myometrium.When moving on to the second stitch after passing the first needle, the doctor found that the tip of the needle had been broken.The needle was also unusually bent.The broken needle tip is not found.There is possibility that the piece is left inside the patient.X-ray and ct scan were inconclusive.It was not a control release needle.The patient was hospitalized.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional h6 investigation findings: c22 - photo review.Additional h6 component code: g07002 no device problem.Additional h3 investigation summary: the product was returned to ethicon for evaluation.One open box with one unused open sample and twelve representative unopened samples was received for analysis.Product code y399h.Additionally, two photos were provided, and it showed a foil packet with two needle-suture pieces and one box with thirteen foil packets.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the condition of the returned samples, the swage and attachment area were noted to be as expected.The tip and body of the needles were examined under magnification and no anomalies or issues related to bent or breakage needle could be observed during the evaluation.In addition, the sample was tested by resistance test to the needle and met the requirements.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.The device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested, and the following was obtained: please explain why the patient was hospitalized and provide details about the hospitalization.This information was obtained next day of initial procedure, so the patient was still hospitalized.Please provide the patient's demographic information including age, weight, bmi at the time of index procedure unk.Date of index surgical procedure? (b)(6)2024.What was the tissue condition (normal, thin, calcified, fragile, diseased)? no special.Condition was reported what instruments were used to grasp the needle? needle holder.Where was the needle grasped during use? unk.Does the needle piece remain retained in the patient's tissue? it's unclear despite the surgeon did both x-ray scan and ct scan.If the piece(s) were retained, where are they located/in what structure? unk.If retained, were there any patient consequences? no.If retained, are there plans for removal of any remaining fragments? it's unclear despite the surgeon did both x-ray scan and ct scan.Please describe any medical/surgical intervention required for this suture event including dates and results.No action so far.Other relevant patient history/concomitant medications? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unk.What is the patient's current status? no more consequence was reported.Will product be returned? if so, please provide the return date and tracking information.The device has been received and will be shipped.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: d9, h6.An additional product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional h3 investigation summary: the product received for analysis was y399h, visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the tip of the needle.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The needle was noted with marks that appears to be by surgical instrument.The evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.The evaluation of the sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage and a cup-and-cone shaped fracture observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: MCRYL VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20642486
• Report Number: 2210968-2024-11730
• Device Sequence Number: 20674504
• Product Code: GAN
• UDI-Device Identifier: 10705031059108
• UDI-Public: (01)10705031059108(17)270430(10)SEMEAK
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: Y399H
• Device Lot Number: SEMEAK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 11/20/2024; 12/16/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/04/2024; 12/16/2024; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female